LCP 223.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982157997), received between Mar 5, 2017 and May 19, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684, K082807); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON POST-OP INSPECTION OF THE ITEMS, THE PLATE WAS BENT, THE SUPRAPATELLAR CADDY WAS BENT AND THE LID DID NOT FIT. THE ANS INSERTS HAD WHITE RESIDUE AND THE SAMURAI SWORD WAS DEFORMED. THE BENDERS HAD RUST ON THEM. NONE OF THE DEVICES WERE CHARGED TO THE FACILITY. THERE WERE NO PATIENT CONSEQUENCES/ OUTCOMES. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 10 HOLES 137MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962909 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9851125 ↗
• InjuryJan 8, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A ONE (1) 3.5MM LOCKING COMPRESSION PLATE WITH 10 HOLES AND EIGHT (8) SCREWS IMPLANTED ON A PRIMARY SURGERY FOR A MIDSHAFT HUMERUS FRACTURE. THE PATIENT PRESENTED AFTER A FALL WITH A BENT PLATE. THE PLATE DID NOT BREAK AND THE SCREWS DID NOT PULL OUT. THE PATIENT TOLD THE SURGEON THE HARDWARE HAD FAILED AND THREATENED LITIGATION. PATIENT STATUS AND OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 8). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9566862 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF PLATES AND SCREWS DUE TO MAL-REDUCTION OF AN ULNA FRACTURE THAT WAS PLATED AT A DIFFERENT LOCATION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) LOCKING COMPRESSION PLATE AND SIX (6) UNKNOWN CORTEX SCREWS. THE SURGEON VERBALIZED THAT IT WAS DONE APPROXIMATELY 7 MONTHS AGO AND MAYBE SCREW PLACEMENT WAS THE REASON FOR FAILURE. ALL HARDWARE ARE INTACT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS COMPLETE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8793125 ↗
• InjuryMay 2, 2019Material Deformation; Material Deformation

  THE PATIENT WAS INITIALLY OPERATED ON (B)(6) 2019. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8574496 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) AND SIX (6) CORTEX SCREWS. ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION OF AN ULNA. DURING THE PROCEDURE, IT WAS OBSERVED THAT AROUND 15MM PIECE OF BONE WAS MISSING FROM THE NON-UNION SITE. THE LCP PLATE AND SIX CORTEX SCREWS WERE THEN REMOVED. A 10-HOLE LOCKING COMPRESSION PLATE (LCP) PLATE WAS REMOVED ALONG WITH SIX (6) 3.5 CORTEX SCREWS. IMPLANTS WERE REMOVED INTACT. A NEW 12-HOLE 3.5 LCP PLATE AND 3.5 LOCKING AND CORTEX SCREWS WERE PLACED IN THE PATIENT. A 15MM PIECE OF TRICORTICAL BONE FROM PATIENT¿S ILIAC CREST WAS USED TO REPLACE MISSING BONE FROM ULNA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS LESS THAN DESIRABLE TREATMENT OUTCOME REPORTED DUE TO NON-UNION. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 10 HOLES 137MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7638914 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT MIDSHAFT RADIUS FRACTURE ON AN UNKNOWN DATE. A 3.5MM 10 HOLE LOCKING COMPRESSION PLATE (LCP) AND NINE (9) SCREW WERE IMPLANTED AT THAT TIME. ON AN UNKNOWN DATE, PATIENT DEVELOPED AN ABSCESS INFECTION ON THE LEFT FOREARM. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS SUCCESSFULLY REMOVED. DURING THE REMOVAL PROCEDURE, ONE (1) CORTEX SCREW WAS NOTED TO BE BROKEN, ALSO REMOVED SUCCESSFULLY. (B)(4).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 7332681 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPAEDIC FIXATION PROCEDURE ON HER RIGHT LEG AND ANKLE ON (B)(6) 2013. THE PATIENT REPORTED THAT THE BONE HEALED HOWEVER, SHE WAS IN CHRONIC PAIN AND HAD EXPERIENCED LIMITED RANGE OF MOTION, AND AS A RESULT, SHE HAD TWO (2) OF THE EIGHT (8) PINS (SCREWS) REMOVED FROM HER ANKLE ON (B)(6) 2013. NO REPORTED SURGICAL DELAY OR PATIENT HARM. IN (B)(6) 2014, THE PATIENT RESUMED PHYSICAL THERAPY, AND FELT BETTER FOR ABOUT TWO-THREE MONTHS, HOWEVER SHE BEGAN HAVING THE PAIN AGAIN, IN A DIFFERENT PLACE. SHE STATED THAT SHE WOULD EXPERIENCE SHARP SHOOTING PAIN GOING UP THE BACK OF HER LEG. IN 2016, PATIENT STATED THAT SHE BEGAN RECEIVING TREATMENT. ON (B)(6) 2017, THE PATIENT HAD SURGERY TO HAVE THE HARDWARE FROM HER ANKLE REMOVED. NO REPORTED SURGICAL DELAY OR PATIENT HARM. THIS REPORT ADDRESSES THE SECOND REMOVAL PROCEDURE ON (B)(6) 2017. RELATED COMPLAINT (B)(4) ADDRESSES THE FIRST PROCEDURE ON (B)(6) 2013. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7216763 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPAEDIC FIXATION PROCEDURE ON HER RIGHT LEG AND ANKLE ON (B)(6) 2013. THE PATIENT REPORTED THAT THE BONE HEALED HOWEVER, SHE WAS IN CHRONIC PAIN AND HAD EXPERIENCED LIMITED RANGE OF MOTION, AND AS A RESULT, SHE HAD TWO (2) OF THE EIGHT (8) PINS (SCREWS) REMOVED FROM HER ANKLE ON (B)(6) 2013. NO REPORTED SURGICAL DELAY OR PATIENT HARM. IN (B)(6) 2014, THE PATIENT RESUMED PHYSICAL THERAPY, AND FELT BETTER FOR ABOUT TWO-THREE MONTHS, HOWEVER SHE BEGAN HAVING THE PAIN AGAIN, IN A DIFFERENT PLACE. SHE STATED THAT SHE WOULD EXPERIENCE SHARP SHOOTING PAIN GOING UP THE BACK OF HER LEG. IN 2016, PATIENT STATED THAT SHE BEGAN RECEIVING TREATMENT. ON (B)(6) 2017, THE PATIENT HAD SURGERY TO HAVE THE HARDWARE FROM HER ANKLE REMOVED. NO REPORTED SURGICAL DELAY OR PATIENT HARM. THIS REPORT ADDRESSES THE FIRST PROCEDURE ON (B)(6) 2013. RELATED COMPLAINT (B)(4) ADDRESSES THE SECOND REMOVAL PROCEDURE ON (B)(6) 2017. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7216722 ↗
• InjuryMar 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO NONUNION. THE PATIENT INITIALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF MID-SHAFT ULNA APPROXIMATELY EIGHT (8) WEEKS PRIOR TO THE DATE OF THIS REPORT (EXACT DATE IS UNKNOWN) TO REPAIR THREE BUTTERFLY BONE FRAGMENTS. IT IS UNKNOWN HOW THE PATIENT SUSTAINED THE FRACTURES. THE PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP), SEVEN (7) UNKNOWN 3.5MM CORTEX SCREWS, AND TWO (2) UNKNOWN 3.5MM LOCKING SCREWS. X-RAYS TAKEN ON UNKNOWN DATE FOR AN UNKNOWN REASON REVEALED THE NONUNION. TWO (2) OF THE THREE (3) BUTTERFLY BONE FRAGMENTS HEALED AND ONE (1) DID NOT. IT IS UNKNOWN IF THE PATIENT REPORTED ANY SYMPTOMS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. ALL HARDWARE WAS REMOVED INTACT. THERE WERE NO ISSUES WITH THE HARDWARE. THE PATIENT WAS REVISED TO BONE GRAFT, ONE (1) 3.5MM LCP PLATE, AND SEVEN (7) SCREWS. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY OR NEED FOR ADDITIONAL MEDICAL INTERVENTION. THE PATIENT¿S POSTSURGICAL STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6379567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K082807. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,